Equipment and Validations Engineer

Job Summary

This role's focus is on the provision of technical guidance, planning coordinating and resourcing validation projects on-site. He/She ensure the qualification and validation of equipment, facilities, utilities and processes are carried out in accordance with GMP and ISO 17025 guidelines

Duties and Responsibilities

• Manage part of the lifecycle for validation projects, including but not limited to, delivering on time, to specification and ensuring the delivery of a quality validation project
• Responsible for developing, preparing the installation of and revising test validation procedures/protocols in accordance with appropriate regulatory agency validation requirements, corporate, internal company standards and currnt industry standards
• Plan, communicate, coordinate and execute simple and complex projects within Charles River Singapore and other sites by using planning tools like Gantt chart, and CPM models
• Write or assist in writing of SOPs for Validation Projects
• Participate in validation project meetins, workshops, training of staff and production of related documentation
• Assist in evaluation of Systems from different vendors for submission of Capital budgetary papers, and to recommend the most appropriate systems, based on User Requirement Specification, and/or other specifications as required from site management and project
• Provide progress reporting and input into established project documentation
• Manage direct relationships with key project stakeholders
• Initiate projects in improve efficiency and productivity of the processes
• Represent the Department in client audits as required as a SME for at least 3 systems
• Assist Manager to perform investigation for the system to bring about process improvement or when required
• Assist Maanger to monitor and trend cost expenditure over a defined period for monitoring of cost effectiveness for the department
• Maintains proper records and documentation of activities that are compliant with good documentation practices, continuous compliance ISO/IEC 17025, cGMP, PIC/S, ISPE Guidelines, WHO Technical Reports, Company global SOPs and other data integrity principles for all activities
• To work closely with all departments to ensure the operation of a validated environment according to existing QMS and/or other regulatory requirements
• Performs all functions as tasked with high degree of accuracy and strict adherence to company's quality requirements
• Reviews aspects/areas for improvement within your own duties/responsibilities and make recommendations to Line Manager for own or team improvements
• Adheres to Company Policies and Procedures
• Undertakes any other duty or responsibility, at the request of Manager that may be required within reason/remit of the role

Job Qualifications

• Bachelor's Degree in Engineering, Biomedical Sciences or any related field
• 3-5 years relevant experience working in an ISO17025 / GMP environment is preferred
• Understanding of IT is expected, related to installation of software, interface of hardware and software and basic administrative controls of Window (such as adding user groups) is preferred
• Understand concepts and rationale, and execute System Commissioning, Qualification and Validation for systems as per requirements stated in ISPE GAMP 5 and USP document is preferred
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
• Effective communication and supervisory skills
• Ability to organize and prioritize work to meet deadlines
• Ability to read, write, speak and understand English